MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Necrosis (1971)

Event Date 06/07/2021

Event Type  Injury  

Event Description

Title: transesophageal echocardiography in patients with magnetic gastroesophageal reflux devices: a report of 2 cases.Authors: shawn h.Malan, kent h.Rehfeldt, jeremy m.Alvord, and bradford b.Smith, citation cite: doi: 10.1213/xaa.0000000000001497.This study represent 2 cases where intraoperative tee was performed in patients with reflux devices without complication or image degradation.The described cases, in addition to a review of the perioperative management of these devices, support the use of tee in this patient population.A (b)(6) woman with a past medical history of gerd, status post-linx device (16 beads) placement presented for deceased donor liver transplantation.End-stage liver disease resulted from acute hepatic injury suffered at the time of the linx device placement, which had been performed at another institution.Specifically, device placement was complicated by common bile duct, left portal vein, and proper hepatic artery injuries, which resulted in intraabdominal abscesses and necrosis of the left lobe of the liver.She was transferred to our institution after failed management of these complications and was found to be a suitable candidate for transplantation that was performed 4 months following linx device placement.The linx device was identified and extracted completely.During extraction of the linx device, the tee probe was left in the midesophagus.Vascular anastomosis included a ¿piggy-back¿ caval reconstruction, common hepatic artery to supraceliac aortic conduit, and a portal vein to portal vein reconstruction.The decision was made to delay definitive reconstruction of the bile duct due to ongoing fibrinolysis, so the abdomen was packed and temporarily closed, and the patient was taken to the intensive care unit (icu) in a stable but critical condition.The patient returned to the operating room the next day for bile duct anastomosis and successful closure of the abdomen.A (b)(6) man with chronic respiratory failure secondary to idiopathic pulmonary fibrosis presented for bilateral lung transplantation.His medical history was significant for gerd, status post-linx device placement (15 beads) 2 years prior, and chronic, progressive respiratory failure with increasing supplemental oxygen requirement.An esophagram performed after linx device placement and before lung transplantation showed mild impedance of anterograde flow across the device.The patient tolerated one-lung ventilation poorly, so the decision was made to proceed with venoarterial extracorporeal membrane oxygenation (va ecmo) via central cannulation to facilitate successful completion of the procedure.Va ecmo flows were initiated, which allowed form single-lung ventilation.After successful anastomosis and adequate ventilation and perfusion, the patient was weaned from va ecmo with subsequent decannulation.Reported complications included a (b)(6) woman with acute hepatic injury, intraabdominal abscesses and necrosis of the left lobe of the liver.A (b)(6) man with mild impedance of anterograde flow across the device.In conclusion the potential for tee-related complications should be understood and minimized by adhering to appropriate precautions and practicing sound clinical judgment.

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: for the a (b)(6) woman with acute hepatic injury, intraabdominal abscesses and necrosis of the left lobe of the liver, does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.For the a (b)(6) man with mild impedance of anterograde flow across the device, does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Manufacturer Narrative

(b)(4).Date sent: 2/28/2022.Additional information: please be advise that this complaint is procedure related and not device related.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13342197
• MDR Text Key: 289219252
• Report Number: 3008766073-2022-00023
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention